Model EEG 4400 with Optional Accessories
FDA 510(k) K874796 · Nihon Kohden America, Inc.
510(k) numberK874796
Submission
- Device name
- Model EEG 4400 with Optional Accessories
- Applicant
- Nihon Kohden America, Inc.
Irvine, CA, US - Received
- November 5, 1987
- Decision date
- January 19, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GWQ – Full-Montage Standard Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations
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| K221959 | Q21GWQ · Traditional | Neurofield, Inc. | 08/31/2023SE |
| K231457 | SPARK ScanGWQ · Traditional | Spark Neuro, Inc. | 08/18/2023SE |
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| K230073 | OktiGWQ · Traditional | Compumedics Limited | 02/09/2023SE |
| K223644 | Neuronaute with IceCap 2 & IceCap 2 SmallGWQ · Special | Bioserenity | 01/12/2023SE |
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| K092573 | Nihon Kohden QP-160AK EEG Trend ProgramOMA · Traditional | 07/09/2010SE |
| K083456 | Nihon Kohden CO2 Sensor Kit, Model TG-970PCCK · Special | 03/02/2009SE |
| K083271 | BSM-2300 &BSM6000 with CGS-9001 Series Communication Gateway, Model CGS-9001 Series…MHX · Special | 12/24/2008SE |
| K082785 | Nihon Kohden Bedside Monitor, BSM 9100A SeriesMHX · Special | 11/26/2008SE |
| K071969 | SEN-4100 Electric StimulatorGWF · Traditional | 10/06/2008SE |
| K080546 | Nihon Kohden EEG-1200A Series Neurofax, Model EEG-1200AOLT · Special | 08/29/2008SE |
| K073550 | Prefense EDNS-9000 Series Nurse Central StationMHX · Special | 03/28/2008SE |
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Questions and answers
When was Model EEG 4400 with Optional Accessories cleared by the FDA?
Model EEG 4400 with Optional Accessories (K874796) received a 510(k) decision of Substantially Equivalent on January 19, 1988, 75 days after the submission was received.
What is the product code of K874796?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.